Jennifer Fuson's blog

After 23 months, the U.S Food and Drug Administration (FDA) has finally agreed to look at the huge safety discrepancy between generic and brand named drugs.  The FDA signaled the move by notifying the Office of Management and Budget of its plans to publish a proposed new rule that would make create similar requirements for generic and brand-name drug makers with respect to how they update their warning labels.

In response to Monday's Supreme Court decision in Mutual v. Bartlett, ruling that generic drug companies cannot be held responsible for the design of the drugs they make, members of Congress have sent a letter to the FDA urging for action to address the disparity between the safety requirements for brand and generic drugs.

The U.S. Supreme Court gave pharmaceutical companies another gift today, largely shielding the generic industry from lawsuits for the design of their drugs.  This is the second Supreme Court decision giving the generic drug industry immunity.

An outdated economic model allows unsafe trucking companies to operate on U.S. roads, according to a new report released today by the American Association for Justice (AAJ).  “Truck Safety Alert: Rising Danger from Trucks and How to Stop It” details safety hazards in the trucking industry, including a compensation program that promotes fatigued driving and ignores safety risks, as well as  inadequate insurance limits that shift the cost burden to taxpayers, medical insurance carriers, and Medicare.

Michelle Garcia of Miami never thought a simple doctor’s office procedure for birth control would result in the removal of both of her fallopian tubes.  Yet last year Michelle underwent surgery to remove Essure, a medical device marketed as a “surgery-free permanent” birth control procedure. It was supposed to be Michelle’s easy solution for birth control for life; instead, it was her worst nightmare, requiring surgery to remove the coils and both damaged fallopian tubes.

Women suffer disproportionately from faulty drugs and medical devices, and Michelle is just one example.  As part of National Women’s Health Week, the American Association for Justice (AAJ) has released “Unequal Harm: The Disproportionate Damage to Women from Dangerous Drugs and Medical Devices,” an analysis detailing a history of a few of the many products that have harmed women over the years.

As if we needed another example of the need to hold generic drug makers accountable to the same standard as brand names, there is this disturbing story from The New York Times. A drug maker named Ranbaxy was churning out generic versions of a number of common drugs, including the epilepsy drug, gabapentin.  But in 2007, it admitted to the Food and Drug Administration that certain batches of the drug had tested positive for “unknown impurities.” 

78% of 2012 CPSC Recalls from Foreign Makers According to Analysis

Taxpayers and patients could pay the price for faulty metal-on-metal hips when the U.S. Food and Drug Administration (FDA) reclassifies several metal-on-metal hips, requiring manufacturers to complete a premarket approval application (PMA) or product development protocol (PDP) in order to receive the agency’s approval.  The reclassification may put patients’ legal rights in question.

Generic drugs make up 80% of all prescriptions filled in the United States, and roughly 53 billion dollars in sales.  Despite that, the U.S. Supreme Court recently held in Pliva v. Mensing that generic drug manufacturers have no responsibility to update their warning labels when they learn of new side-effects.  As a result, generic drug makers cannot be held accountable, even if their drug injures or even kills someone. The Supreme Court left it to Congress to change the law.  

Read the real story of Camille Baruch to learn how the access of justice has been denied for generic drug patients.  

Congress needs to amend the law to allow both generic and brand manufacturers to be responsible for their drugs’ safety.  Send a message to your member of Congress today!